Clinical Outcomes of ACL Reconstruction Augmented by an Injectable Osteoconductive/Osteoinductive Compound

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University of Miami

Status and phase

Completed
Phase 3

Conditions

ACL Injury

Treatments

Drug: OOC

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT04993339
20150981

Details and patient eligibility

About

The goal of this study is to determine whether the use of injectable osteoinductive/osteoconductive compounds (OOC) during Anterior Cruciate Ligament (ACL) reconstructive surgery, combined with an accelerated rehabilitation protocol (ARP) provides clinical outcomes superior to those attained via traditional ACL reconstruction and delayed rehabilitation protocols.

Enrollment

26 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

any adult undergoing a surgical procedure for hamstring ACL reconstruction

Exclusion criteria

  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women
  • Prisoners

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

26 participants in 2 patient groups

Standard Surgery
No Intervention group
Description:
Participants in this group undergoing standard of care reparative surgery will not receive additional intervention
Standard Surgery with OOC
Experimental group
Description:
Participants in this group undergoing standard of care reparative surgery will receive OOC as an additional intervention
Treatment:
Drug: OOC

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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